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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03354104 |
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Date of registration:
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08/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tunnel Technique With Emdogain® in Addition to Connective Tissue Graft Compared With Connective Tissue Graft Alone for the Treatment of Gingival Recessions: a Randomized Clinical Trial.
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Scientific title:
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Tunnel Technique With Emdogain® in Addition to Connective Tissue Graft Compared With Connective Tissue Graft Alone for the Treatment of Gingival (Periodontal?) Recessions: a Randomized Clinical Trial. |
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Date of first enrolment:
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January 22, 2018 |
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Target sample size:
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30 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03354104 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Poland
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Contacts
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Name:
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Batlomiej Gorski, DDS, PhD |
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Address:
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Telephone:
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+48 22 502 20 99 |
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Email:
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Affiliation:
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Name:
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Tomasz Kaczynski, DDS |
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Address:
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Telephone:
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+48 22 502 20 99 |
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Email:
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t.kaczynski@me.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age = 18 years
- Bilateral multiple gingival recessions in homologous teeth
Exclusion Criteria:
- Full-mouth plaque index = 20% (Ainamo & Bay 1975)
- Full-mouth sulcus bleeding index = 15% (Mühlemann & Son 1971)
- Smoking
- Systemic diseases with compromised healing potential of infectious diseases
- Drugs affecting periodontal health / healing
- Pregnant and lactating females
- Previous periodontal surgery in the area
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gingival Recession
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Intervention(s)
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Device: The tunnel technique for root coverage without Emdogain
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Device: The tunnel technique for root coverage with Emdogain
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Primary Outcome(s)
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Clinical attachment level (CAL)
[Time Frame: 6 months after surgery]
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Secondary Outcome(s)
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Average recession coverage (ARC)
[Time Frame: 6 months after surgery]
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Thickness of keratinized tissue (TKT)
[Time Frame: 6 months after surgery]
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Width of keratinized tissue (WKT)
[Time Frame: 6 months after surgery]
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Recession width (RW)
[Time Frame: 6 months after surgery]
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Recession height (RH)
[Time Frame: 6 months after surgery]
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Complete recession coverage
[Time Frame: 6 months after surgery]
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Secondary ID(s)
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WUM.PERIO.01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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